Kornimate/medical-research-clean huggingface dataset:
study of vitamin b12 metabolism in children with sickle cell disease exposed to meopa

Conditions: Sickle Cells Patients

Summary: short description of the protocol intended for the lay public. include a brief statement of the study hypothesis (limit : 5000 characters) the sickle cells anemia is a monogenic disease linked to the presence of hemoglobin s due to a mutation in the hemoglobin beta chain. the lack of circulating oxygen induces a polymerization of the hemoglobin s which change the red cell conformation into sickle. those cells interact and causes vaso-occlusive crisis (cvo). the meopa is a medical gas used as an antalgic and a sedative especially in sickle cells disease patients. the nitrous oxide, oxide the cobalt ion in the vitamin b12 which inactivate it irreversibly creating a functional deficiency. during the metabolism of vitamin b12, homocysteine is transformed in methionine which is used in to form the myelin sheath and helped in producing dna. numerous studies already shown that the longer the exposition to meopa is the greater the functional deficiency of vitamin b12 occur. a few studies shown a symptomatic deficiency of vitamin b12 due to the exposition of meopa in sickle cells patient but there is no explanation on the necessary amount of exposure or if some patients are more at risk. when there is a deficiency of vitamin b12 the symptoms can go from a simple orthostatic hypotension to a combined spinal sclerosis. the participation to the study will be proposed to every patient hospitalized for a cvo in the follow up of the emergency room visit or directly in pediatric reanimation. during a usual blood test, a small amount of blood (4ml) will be collected in addition to dose the vitamin b12, the vitamin b9, the homocysteine, and the methionine. a small amount of urine will also be collected to dose the methylmalonic acid, all those elements are a part of the metabolism of b12 vitamin. the same sample will be taken on the day of departure of the hospital. during the hospitalization the pain management, a daily neurological exam, and the exposition to the meopa will be assessed meticulously. an appointment will take place at 7 days and at one month after the hospital departure to evaluate the possible neurological defect. each patient can only be included once.


Eligibility criteria:
inclusion criteria: * sickle cells patient * age between 2 and 18 years old * being affiliated with social security exclusion criteria: * having a neurological defect prior to the study * being against the collection of blood or data
evaluating a digital intervention for overactive bladder

Conditions: Overactive Bladder

Summary: overactive bladder is characterised by (i) urgency: the sudden and compelling desire to pass urine with or without accidental leakage; (ii) frequency: the need to pass urine far more regularly than is considered normal; and (iii) nocturia: the need to pass urine several times during the night. this study aims to investigate the feasibility, acceptability and preliminary efficacy of a digital intervention (the nuig oab app) for overactive bladder. furthermore, this study will help determine the most appropriate outcomes for use in the future definitive rct and the effect size for future sample size calculations. participants will complete an 8-week intervention designed to reduce the symptoms of oab, delivered through the nuig oab app. participants will be asked to complete online surveys at baseline, 4 weeks and 8 weeks and an in-app bladder diary at weeks 1 and 8. there will be no in-person contact with participants by the study team.


Eligibility criteria:
inclusion criteria: 1. on waiting list for urogynaecologist at participating hospital 2. referred for overactive bladder from gp 3. symptoms of overactive bladder to include at least one of the following: urgency of urination, frequency of urination or urge incontinence. 4. female 5. 18 years or older 6. own a smartphone exclusion criteria: 1. active/recurrent urinary tract infection 2. urinary retention 3. bladder pain syndrome/ interstitial cystitis 4. pelvic/gynae cancer 5. pregnant 6. dementia 7. kidney problems 8. stroke 9. have/had a neuro-stimulation implant for treatment of oab
tsa exercise prehabilitation in older adults

Conditions: Postoperative Delirium and Delayed Functional Recovery

Summary: this is a randomized study to examine whether aerobic exercise training (aet) before total shoulder replacement (tsr) surgery reduces the incidence of post-operative delirium (pod) and shorten time to recovery in elderly patients. pod is a form of sudden change in mental function that can be experienced after undergoing surgery.

this randomized clinical trial will determine whether aerobic exercise training (aet) before total shoulder replacement (tsr) surgery reduces the incidence of post-operative delirium (pod) and shortens time to recovery in elderly patients. delayed recovery affects up to 30% of surgical patients and imposes enormous costs on patients, caregivers, and society. patients over 65 are four times more likely to experience pod, a form of sudden change in mental function that could be experienced after undergoing surgery. pod is associated with impaired daily functioning, longer hospital stay, more frequent institutionalization, and increased mortality. prevention of pod is a high clinical priority. evidence suggests that an exaggerated inflammatory response contributes to pod. human studies show that aet may exert anti-inflammatory effects. furthermore, recent animal data show that aet attenuates the inflammatory response to surgery and prevents associated cognitive dysfunction. the trial will enroll elderly patients undergoing tsr surgery to examine whether a low-cost intervention before surgery can improve clinical outcomes (reduction in pod and decrease recovery time). the effects of a 4-week aet program, specifically a type known as high-intensity interval training (hiit), on the incidence of pod and time to recovery from fatigue and functional impairment. we will also analyze patients' immune state before and after surgery with modern techniques (high-dimensional mass cytometry). understanding the immune-modulatory effects of aet will reveal mechanisms that can be targeted by interventions other than or in addition to exercise, which may benefit patients who are physically disabled or require urgent surgery, and help identify non-surgical diseases that may benefit from exercise.

Eligibility criteria:
patients scheduled for total shoulder replacement

Keywords: aerobic exercise training delirium
study to measure the safety of 68ga-dota-tate pet/ct in the diagnosis of tumors expressing somatostatin receptors

Conditions: Neuroendocrine Tumors

Summary: phase-ii, prospective, open label, no control group to assess the safety of 68ga-dota-tate injection in patients with suspected or diagnosed with tumors expressing somatostatin receptors. each included patient will receive an administered dose of 50 mcg or less of the peptide (dota-tate) and a range of activity between 100 - 200 mbq of 68ga-dota-tate. the efficacy of 68ga-dota-tate in assessing this kind of tumors has been proved by numerous studies.


Eligibility criteria:
inclusion criteria: 1. patients with suspected or proven tumors expressing somatostatin receptors 2. informed consent by patient (or parents if patient is less than 18 years of age) exclusion criteria: 1. pregnancy (confirmed). in the case of a diagnostic procedure in a patient who is or may be pregnant, a clinical decision is necessary considering the benefits against the possible harm of carrying out any procedure. 2. patient refusal to participate. 3. impossibility to tolerate a decubitus position for 25 minutes 4. prior allergic reaction to dota-tate or somatostatin analogs
spontaneous retinal artery pulses (spars) as a prognostic determinant of central retinal vein occlusions (crvo) in patients with or without intravitreal aflibercept injections

Conditions: Central Retinal Vein Occlusion

Summary: central retinal vein occlusion (crvo) is the second most common retinal vascular disease after diabetic retinopathy. it induces circulatory slowdown and blood stasis, which can appear as retinal hemorrhages. crvo has been classically separated into two clinical forms: ischemic cvro (possibly associated with cotton wool spots) and non-ischemic crvo, the former being considered the most serious due to neovascular complications. more recently, a new classification has been suggested by pierru et al. distinguishing two types of crvo: type a characterized by low acute blood flow and type b with a slower onset. type a is particularly associated with younger age, the presence of acute paracentral middle maculopathy, concomitant cilioretinal artery occlusion, and/or pulsatile arterial filling. type b is more likely to occur in elderly patients, usually with high blood pressure, and multiple hemorrhages are frequently found on fundus examination. a retrospective study had shown a slight difference in favor of pulsatile crvo in terms of the number of intravitreal anti-angiogenic injections required to treat macular edema and visual acuity changes. however, no statistically significant difference was observed. the objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (spars) in patients with type a or b crvo can be considered as a prognostic factor for the evolution of crvo.

in order to be able to interpret the results on a homogeneous population, given that several molecules have marketing authorization for the management of macular edema following a crvo, the therapeutic management will be standardized by the use of aflibercept for patients requiring intravitreal injection, aflibercept being the most widely referenced treatment currently used in the participating centers.

Eligibility criteria:
inclusion criteria: * diagnosis of crvo, with or without macular edema. * onset of symptoms in the previous month (maximum 30 days prior to inclusion) * naive of intravitreal injection and intravitreal corticosteroid implant * if woman of childbearing age: commitment to effective contraception during treatment with aflibercept and for at least 3 months after the last intravitreal injection of aflibercept exclusion criteria: * pregnant or breastfeeding woman * history of stroke or myocardial infarction in the last 3 months * retinal detachment or untreated retinal dehiscence * opacity of ocular media * amblyopia * diabetic retinopathy * macular edema of a different etiology than crvo * active or suspected ocular or periocular infection * severe intraocular inflammation * hypersensitivity to eylea® : to the active substance (aflibercept) or to one of the excipients

Keywords: central retinal vein occlusion spontaneous retinal artery pulsation
polysomnography and heart rate indexes in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (osa). this includes evaluation of polysomnography indexes (ahi; ai, arousal index; odi, oxygen desaturation index) and heart rate variability (hrv) indexes.

this is a cross-sectional study collecting data from patients from the sleep institute of itaperuna, rio de janeiro, brazil. polysomnography (psg) monitoring and diagnosis was in accordance with american society of sleep medicine (assm) standards. standard baseline polysomnography is performed using a computerised system. the following extracted signals are measured: 2 electroencephalogram channels (o1-a2, o2-a1, c3-a2, c4-a1), 2 electrooculogram channels, electromyography (emg, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ecg derivation dii). the polysomnograms are scored according to the criteria of rechtschaffen and kales.

Eligibility criteria:
inclusion criteria: * diagnosis of obstructive sleep apnea with an apnea-hypopnea index (ahi) \> 5. exclusion criteria: * subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.

Keywords: obstructive sleep apnea polysomnography heart rate variability mathematical biomarker
adenoma detection rate in water and air colonoscopy using computer-aided system

Conditions: Colon Adenoma; Colonoscopy

Summary: water exchange (we) is an effective insertion method to minimize insertion discomfort and maximize adr. it is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. a modified delphi review reported water exchange showed the highest overall adr, adr in screening cases, and in the right side of the colon compared with water immersion and air (or co2) insufflation. one of the plausible mechanisms of improving adr by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. however, no rct has been performed to evaluate the effect of cade on we colonoscopy. therefore, investigators will conduct a rct comparing the adr of cade assisted colonoscopy inserted with either we or insufflation. our hypothesis will be that cade assisted we colonoscopy achieves higher adr than cade assisted air insufflation colonoscopy.

the primary end point will be adr, defined as the proportion of patients with at least one adenoma. serrated lesions will not be counted as part of adr. secondary outcomes were fp rate, adenomas per colonoscopy (apc), polyp detection rate, polyps per colonoscopy, sl detection rate, cecal intubation rate, withdrawal time. missed polyp will be defined as a polyp recognized by endoscopist, but is not detected by cade system at an interval of 2 seconds. the detected polyps will be classified in sizes, morphology (polypoid or nonpolypoid). investigators also record the detection of every polyp by the endoscopist or the cade system in time priority. if a polyp is detected by performing endoscopist at the same time as the cade system, the credit will go to the endoscopist. the colonoscopy procedure will be recorded as cade over-laid videos and be reviewed for fp characteristics, numbers and appearance time afterward. the withdrawal time will be divided into inspection time, cleaning time and polypectomy time. boston bowel preparation scale score and the amount of water infused and aspirated will also be recorded.

Eligibility criteria:
inclusion criteria: * consecutive patients, undergoing screen, diagnostic or surveillance colonoscopy performed by the participating endoscopists will be enrolled. exclusion criteria: * we excluded patients age \ 80 years old, undergone colonoscopy in the past 3 years, partial intake of bowel preparation, renal failure, previous colonic resection, scheduled for polypectomy, american society of anesthesiology (asa) risk class 3 or higher, and lack of written informed consent.

Keywords: adenoma detection rate, computer-aided system
a study of the safety and efficacy of intelligent powered exoskeletons in postoperative spinal rehabilitation

Conditions: Exoskeleton Device

Summary: systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. in order to evaluate the safety and efficacy of the smart power armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.


Eligibility criteria:
inclusion criteria: * age 18-70 years old; * spinal surgery within 1 year due to degeneration, tumor, trauma or other reasons, postoperative motor disorders of both lower limbs, such as muscle weakness (3-5 level reduction), increased muscle tone, gait incoordination caused by deep sensory loss, etc.; * the patient does not have a plan to rehabilitate in a specialized rehabilitation hospital, and plans to rehabilitate at home; exclusion criteria: * short expected survival from malignant diseases; * muscle strength is less than grade 3, and the muscles of both lower limbs are severely atrophied; * suffering from other neurological diseases; * planned to undergo other surgeries within 3 months; * unable to cooperate with the transmission power external armor or cooperate with the rehabilitation training due to the physical condition;

Keywords: hip exoskeleton device spinal cord injuries rehabilitation
prone position emergence from anaesthesia in lumbar disc surgery

Conditions: Haemodynamic Changes During During Emergence; Airway Response During Emergence; Monitor Disconnection During Emergence

Summary: compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine position.

tracheal irritation from the endotracheal tube, with subsequent coughing is common during emergence from general anaesthesia supine position and is often thought not to be a complication, but a physiological response to protect the airway from aspiration, although the side-effects of this vital reflex may be highly undesirable in clinical practice. coughing not only causes significant patient discomfort, but it may also cause hypertension, tachycardia, and increased intracranial, intraocular, and intra-abdominal pressure, which may lead to myocardial ischemia, arrhythmias, or surgical complications. supine extubation also leads increased incidences of breath holding, laryngospasm, coughing, and monitor disconnection. these haemodynamic and airway responses are largely related movement of endotracheal tube during rolling of patients back to supine position during lighter depth of anaesthesia at conclusion of surgery. coughing, breath holding, and laryngospasm also related to pooling of secretions to dependent patients airway in supine position. various techniques and drugs for the prevention of cardiovascular response and coughing during emergence have been studied, including extubation in a deep plane of anaesthesia, administration of intravenous drugs such as esmolol, lidocaine, short-acting opioids, or dexmedetomidine, and intracuff lidocaine. a reliable means of preventing undesired coughing has not been demonstrated to date. emergence in prone position has been found to be associated with less hemodynamic alterations, less coughing, laryngospasm, vomiting and monitor disconnections in patients undergoing lumbar surgery. there is a paucity of data regarding safety and efficacy of emergence from anaesthesia in prone position. the investigators present our initial experience of emergence from anaesthesia in prone position as compared to supine position in normotensive patients undergoing lumbar surgery in prone position.

Eligibility criteria:
inclusion criteria: * age between 18-60 years * prone surgery * lumbar disc surgery exclusion criteria: * suspected difficult airway, * risk factors for perioperative aspiration, * chronic coughing, * recent history of respiratory tract infection, * chronic obstructive lung disease and * obesity

Keywords: prone emergence supine emergence coughing haemodynamic stimulation lumbar surgery
total laparoscopic versus open aortic surgery for abdominal aortic disease

Conditions: Graft Occlusion, Vascular

Summary: this prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (aod) and infra-renal aortic aneurysmal disease (aaa) in comparable groups of patients using a propensity analysis model.

from january 2006 to january 2010, 228 consecutive patients who received an aortic bypass for aaa (n=139) or for aod (n=89) were studied. open repair was performed in145 patients (aaa=109, aod=36) and total laparoscopic repair in 83 patients (aaa=30, aod=53). one-to-one propensity score matching between study groups was done according to a difference in the logit of propensity score of less than 0.04 between each patient pairs in the study groups. logistic regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating postoperative and long-term outcome. a p value \< .05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * aortic occlusive disease (tasc c \& d) * aortic abdominal aneurysm with a diameter \> 5 cm exclusion criteria: * patients with an occlusive disease amenable to stenting (tasc a \& b) * patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (evar) * patients with a life expectancy \< 3 years or asa 4 with a high operative risk
pinch grip and functional outcomes between hematoma distraction arthroplasty versus ligament reconstruction tendon interposition arthroplasty in trapeziometacarpal osteoarthritis.

Conditions: Osteoarthritis Thumbs; Rhizarthrosis; Trapeziometacarpal (TMC) Arthrosis

Summary: to date, there is no gold standard for the treatment of severe trapeziometacarpal joint osteoarthritis. despite the fact that new procedures have been described, techniques such hematoma distraction or ligament reconstruction tendon interposition are still valid non-implant options. the main hypothesis was that patients treated with ltri technique would show superior clinical outcomes at one-year follow-up in terms of tip and key pinch and dash scores in comparison with hda technique. as secondary objectives, complication rates and surgical times were recorded.


Eligibility criteria:
inclusion criteria: patients who attended the hand unit's outpatient clinic at a regional trauma center with a diagnosis of grade iii-iv tmc oa according to the eaton-littler radiological scale, who had previously failed conservative treatments (nsaids, splints, rhb, and corticosteroid injections) and desired surgical intervention with sufficient comprehension to participate in this study. exclusion criteria: previous procedures on the same extremity distal to the elbow, central or peripheral neurological disease, and patient withdrawal.

Keywords: osteoarthritis thumb rhizarthrosis trapezectomy arthroplasty